Karmic Lifesciences, a leading Indian CRO headquartered in Mumbai yesterday announced the grand opening of its new state-of-the-art 12,000 sq. ft. CRO facility at Airoli SEZ, Navi Mumbai. The new facility is located in a Special Economic Zone at Raheja Mindspace, Thane Belapur Road, Airoli which is one of the upcoming SEZ parks in the city and has state-of-the-art facilities including Fully Secure, Biometrics Access, a Fire-Proof, Humidity Controlled Central Archival Room, an Investigational Product Storage facility with upto -80 C ambient temperatures, high-end rack servers, secure firewall and dedicated VPN connectivity.
Karmic celebrated the event with a Grand Inauguration Ceremony and Address by Hon. Shri Ramesh Bagwe, Minister of State for Food & Drug Association. Shri Bagwe commended the Karmic team for its achievement and mentioned that many more such start-ups should emerge in the burgeoning Clinical R&D space and leverage India’s significant medical talent, strong patient base and a robust Regulatory and IP protection regime to create value.
The inauguration was attended by over 200 guests including key industry stakeholders from IDMA, OPPI etc. as well as several Pharma Companies, Investigators and Academicians who graced the occasion and took part in an informal interaction with the Minister. Several members of the media including Express Pharma, Pharma Bio, Bio-Spectrum, Times of India, Hindustan Times, Lokmat etc. were also present and actively covered the event.
As one of India’s fastest growing CROs, it was the next logical step for Karmic to move to a much larger facility and Karmic views this event as a major element in strengthening its positioning for global clients including US and Europe. Incorporated in 2005, the company completes 5 years of operations on 10th August, 2010.
Ms. Nidhi Saxena, Founder & CEO of Karmic Lifesciences commented “The new facility is a step towards getting to best-in-class and will help us showcase ourselves as a technology savvy CRO and ensure full compliance to US-FDA and 21 CFR Part 11 standards. We will further be going in for ISO 27001 (BS7799) certification shortly and will provide platinum standard data security to our global clients. This move comes up with several other initiatives we have embarked upon since we raised capital earlier this year including strengthening the team, enhancing Oncology Trial capabilities, developing a low cost EDC solution, setting up a preferred site network on a pan-India basis and setting up a full-fledged sales operation in the US.
Dr. Shreekant Sapatnekar, the company’s Medical Director & COO said “This is our moment of pride and takes us to a different league from an Operational and IT capability perspective. Apart from expanding our overall operations, this move will give a strong fill-up to our formidable Clinical Data Management capability and establish us as one of the CDM leaders from India. We are already talking to several clients who are looking at dedicated CDM set-ups in our new facility.”
About Karmic Lifesciences: Karmic Lifesciences is a privately funded, ISO 9001:2000 certified and India’s fastest growing full-service CRO with end-to-end offerings in Clinical Trial Management, Clinical Data Management, Bio-Statistics, Medical Writing, Regulatory Submissions/Consulting and Pharmacovigilance. With a team of approximately 50 professionals, the company has a track record of successfully supporting over 50 ICH-GCP compliant clinical studies and 20 clinical back-office projects across multiple therapeutic areas including Oncology, Neurology, Diabetes, Immunology, Cardiovascular, Gastroenterology, Ophthalmology, Orthopedics, Respiratory etc. Karmic has a state-of-the-art, 21 CFR Part 11 compliant CDM infrastructure with ClinTrial 4.6, Inform EDC, SAS 9.1.3, MedDRA 13.0 and WHO-DD.